132 results
Keyword Octreotide Remove keyword
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Orphan designation: Octreotide acetate for: Treatment of acromegaly
Date of designation: 05/08/2013, Positive, Last updated: 23/01/2019Octreotide acetate Overview On 5 August … Ltd, United Kingdom, for octreotide acetate (oral use) for treatment … of growth hormone) such as octreotide and lanreotide, and pegvisomant … -
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Orphan designation: Octreotide chloride for: Treatment of acromegaly
Date of designation: 12/06/2009, Positive, Last updated: 30/05/2018Octreotide chloride Overview On 12 June … to Camurus AB, Sweden, for octreotide chloride (lipid depot solution … of growth hormone) such as octreotide and lanreotide, and pegvisomant … -
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Octreotide acetate product-specific bioequivalence guidance
Last updated: 08/02/2019Octreotide acetate product-specific … Octreotide acetate product-specific … Octreotide acetate depot powder and …
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Referral: Sandostatin LAR and associated names
ocreotide, Article 30 referrals
Status: European Commission final decision, opinion/position date: 26/06/2014, EC decision date: 26/06/2014, Last updated: 27/06/2014contains the active substance octreotide. Octreotide is a synthetic substance … somatostatin. Like somatostatin, octreotide blocks the release of hormones … hormones. In Sandostatin LAR, octreotide is contained into microspheres … -
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Human medicine European public assessment report (EPAR): Lutathera
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,
, 
, Revision: 4, Authorised, Last updated: 27/01/2021
for patients treated with octreotide, a medicine already approved … for patients treated with octreotide, a medicine already approved … -
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Referral: Sandostatin and associated names
ocreotide, Article 30 referrals
Status: European Commission final decision, opinion/position date: 26/06/2014, EC decision date: 26/06/2014, Last updated: 27/06/2014contains the active substance octreotide. Octreotide is a synthetic substance … somatostatin. Like somatostatin, octreotide blocks the release of hormones … Sandostatin and associated names (octreotide, 0.05 mg/1 ml, 0.1 mg/1 ml … -
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Human medicine European public assessment report (EPAR): Signifor
pasireotide, Acromegaly; Pituitary ACTH Hypersecretion
Date of authorisation: 24/04/2012,, Revision: 13, Authorised, Last updated: 14/08/2020
19% of patients receiving octreotide, another somatostatin analogue … the somatostatin analogues octreotide or lanreotide. Continuation … 19% of patients receiving octreotide, another somatostatin analogue … -
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Orphan designation: pasireotide for: Treatment of acromegaly
Date of designation: 08/10/2009, Positive, Last updated: 13/05/2020of growth hormone) such as octreotide and lanreotide, and pegvisomant … respond to treatment with octreotide. These assumptions will need … of growth hormone) such as octreotide and lanreotide, and pegvisomant … -
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Orphan designation: Lutetium (177Lu) edotreotide for: Treatment of gastro-entero-pancreatic neuroendocrine tumours
Date of designation: 04/06/2014, Positive, Last updated: 05/09/2017treating GEP-NETs, including octreotide, everolimus, and sunitinib … treating GEP-NETs, including octreotide, everolimus, and sunitinib … -
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Orphan designation: Cyclo(-gamma-aminobutyryl-L-phenylalanyl-L-tryptophanyl-D-tryptophanyl-L-lysyl-L-threonyl-L phenylalanyl-N-3-carboxypropyl)-glycine amide, acetate salt for: Treatment of acromegaly
Date of designation: 06/12/2012, Positive, Last updated: 09/02/2016of growth hormone) such as octreotide and lanreotide, as well as … responses in adenoma cells than octreotide and a potentially better … growth hormone) such as octreotide and lanreotide, as well as … -
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National expert: Karl Mikael Kälkner, Medical Products Agency (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 22.73 KB | PDF
by [111In]-labeled DTPA-D-[Phe1]-octreotide scintigraphy. Cancer Res … Westlin JE. [111In-DTPA-D-Phe1]-octreotide scintigraphy in patients … predict therapy outcome with octreotide treatment: a pilot study … -
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National expert: Manel Puig Domingo, European Medicines Agency (updated)
- Declaration of interests - 82.45 KB | PDF
- Curriculum Vitae - 402.49 KB | PDF
01/2017-12/2018 Chiasma oral octreotide acromegaly 01/2018-05/2019 … -
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National expert: Wouter de Herder, European Medicines Agency (updated)
- Declaration of interests - 81.3 KB | PDF
- Curriculum Vitae - 105.61 KB | PDF
1992) Het insulinoom en octreotide. Ned Tijdschr Geneeskd 136 … Reubi JC, Krenning EP (1993) Octreotide and Related Somatostatin … -
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National expert: Jeroen Dekervel, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 80.19 KB | PDF
- Curriculum Vitae - 23.29 KB | PDF
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Orphan designation: (R)-1-[1-(4-acetoxy-3,3-dimethyl-2-oxo-butyl)-2-oxo-5-(pyridin-2-yl)-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-3-(3-methylamino-phenyl)-urea (ceclazepide) for: Treatment of gastro-entero-pancreatic neuroendocrine tumours
Date of designation: 14/12/2015, Positive, Last updated: 02/03/2021treating GEP-NETs, including octreotide and lanreotide for the management … treating GEP-NETs, including octreotide and lanreotide for the management … -
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Orphan designation: R-1-[2,3-dihydro-2-oxo-1-pivaloylmethyl-5-(2-pyridyl)-1 H-1,4-benzodiazepin-3-yl]-3-(3-methylaminophenyl)urea (netazepide) for: Treatment of gastric carcinoid
Date of designation: 14/06/2007, Positive, Last updated: 02/03/2021neuroendocrine cells) such as octreotide and lanreotide were authorised … neuroendocrine cells) such as octreotide and lanreotide were authorised … -
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Orphan designation: Recombinant human monoclonal antibody to insulin receptor for: Treatment of congenital hyperinsulinism
Date of designation: 14/07/2016, Positive, Last updated: 27/08/2020Products such as diazoxide and octreotide were used to reduce insulin … Products such as diazoxide and octreotide were used to reduce insulin … -
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Orphan designation: Glucagon analogue linked to a human immunoglobulin Fc fragment for: Treatment of congenital hyperinsulinism
Date of designation: 25/05/2018, Positive, Last updated: 23/05/2019Products such as diazoxide and octreotide were used to reduce insulin … Products such as diazoxide and octreotide were used to reduce insulin … -
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Orphan designation: Recombinant protein consisting of modified human growth hormone releasing hormone and the translocation and endopeptidase domains of botulinum toxin serotype D for: Treatment of acromegaly
Date of designation: 11/01/2012, Withdrawn, Last updated: 23/05/2019of growth hormone) such as octreotide and lanreotide, and pegvisomant … -
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Orphan designation: Glucagon for: Treatment of noninsulinoma pancreatogenous hypoglycaemia syndrome
Date of designation: 19/11/2018, Positive, Last updated: 18/03/2019Products such as diazoxide and octreotide were used to reduce insulin … -
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Orphan designation: Glucagon for: Treatment of congenital hyperinsulinism
Date of designation: 08/10/2009, Positive, Last updated: 25/01/2019Medicines such as diazoxide and octreotide were used to reduce insulin … Medicines such as diazoxide and octreotide were used to reduce insulin … -
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Orphan designation: 2'-O-(2-Methoxyethyl) phosphorothioate antisense oligonucleotide targeting the growth hormone receptor for: Treatment of acromegaly
Date of designation: 27/06/2016, Positive, Last updated: 03/05/2018of growth hormone) such as octreotide and lanreotide, and pegvisomant … of growth hormone) such as octreotide and lanreotide, and pegvisomant … -
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Orphan designation: Lutetium-177(3+), S2,S7-cyclo[N-{4,7,10-tricarboxymethyl-1,4,7,10-tetraaza-cyclododecan-1-yl-acetyl}-4-chloro-L-phenylalanyl-D-cysteinyl-4-[(4S)-2,6-dioxo-1,3-diazinane-4-carboxamido]-L-phenylalanyl-4-(carbamoylamino)-D-phenylalanyl-L-lysyl-L-threonyl-L-cysteinyl-D-tyrosinamide]- for: Treatment of gastro-entero-pancreatic neuroendocrine tumours
Date of designation: 20/09/2016, Positive, Last updated: 14/11/2016including everolimus, lanreotide, octreotide and sunitinib. Surgery was … including everolimus, lanreotide, octreotide and sunitinib. Surgery was … -
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Orphan designation: Glucagon for: Treatment of congenital hyperinsulinism
Date of designation: 05/03/2012, Positive, Last updated: 19/04/2012Products such as diazoxide and octreotide were used to reduce insulin … Products such as diazoxide and octreotide were used to reduce insulin … -
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Orphan designation: 4-[(3S)-3-aminopyrrolidin-1-yl]-6-cyano-5-(3,5-difluorophenyl)-N-[(2S)-1,1,1-trifluoropropan-2-yl]pyridine-3-carboxamide for: Treatment of congenital hyperinsulinism
Date of designation: 09/12/2020, Positive, Last updated: 27/05/2021Products such as diazoxide and octreotide were used to reduce insulin … Products such as diazoxide and octreotide were used to reduce insulin …